A Study To Estimate The Amount Of CP-690,550 (Study Drug) That Is Absorbed Into The Blood Of Healthy Subjects Following Oral Administration Of CP-690,550 In Tablet Form

Healthy Clinical Trial

Official title:

A Phase 1, Open Label, Single Dose, Randomized, Cross Over Study To Estimate The Absolute Oral Bioavailability Of CP-690,550 In Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01143805
• Other study ID #: A3921077
• Status: Completed
• Phase: Phase 1
• First received: June 9, 2010
• Last updated: August 6, 2010
• Start date: July 2010
• Est. completion date: August 2010

Study information

• Verified date: August 2010
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

In this study, a 10 mg dose of CP-690,550 will be given to study subjects on two separate occasions by two different routes of administration: One time by mouth in tablet form and one time by vein (intravenous form). The amount of CP-690,550 available in the blood following administration by vein will be measured and is expected to reflect the maximum amount possible for the 10 mg CP-690,550 dose. The amount of CP-690,550 that is achieved in the blood following oral tablet administration will also be measured and compared to that achieved following administration by vein in order to estimate how much of the maximum amount possible is actually absorbed into the blood following administration by mouth as a tablet.

Description:

To estimate the absolute bioavailability of a 10 mg oral dose of tasocitinib (CP-690,550) compared to a 10 mg intravenous dose of tasocitinib (CP-690,550) in healthy subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy male and/or female (non childbearing potential)

• Subjects between the ages of 21 and 55 years, inclusive

• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs)

• No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)

Exclusion Criteria:

• Evidence or history of any clinically significant illness, medical condition, or disease.

2. Evidence or history of any clinically significant infections within the past 3 months.

3. Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Tasocitinib 10 mg oral tablet
Treatment A: Single-dose of tasocitinib (CP-690,550) (10 mg) in the form of an oral tablet
• Tasocitinib 10 mg IV Infusion
Treatment B: Single-dose of tasocitinib (CP-690,550) (10 mg) in the form of a 30 minute intravenous infusion

Locations

Country	Name	City	State
Singapore	Pfizer Investigational Site	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUCinf of tasocitinib (CP 690,550)		PK blood samples out to 12 hours post dose	No
Secondary	AUClast, Cmax, Tmax, and t½, CL (IV dose only) and Vss (IV dose only) of tasocitinib (CP 690,550).		PK blood samples out to 12 hours postdose	No
Secondary	Safety Laboratory tests: hematology, chemistry, urine testing		Safety Laboratory testing performed out to 2 days post last dose	Yes
Secondary	Vital Signs: Blood pressure, heart rate, oral temperature		Vital signs out to 2 days post last dose	Yes
Secondary	AE Reporting		Throughout study	Yes

External Links

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